Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Trastuzumab 440mg
Celltrion Healthcare New Zealand Limited
440 mg
Powder for infusion concentrate
Active: Trastuzumab 440mg Excipient: Histidine Histidine hydrochloride Polysorbate 20 Trehalose dihydrate Benzyl alcohol Water for injection
Prescription
Herzuma is indicated for patients with metastatic breast cancer who have tumours that overexpress HER2: - as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or - in combination with taxanes for the treatment of those patients who have not received chemotherapyfor their metastatic disease; or - in combination with a aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.
Package - Contents - Shelf Life: Combination pack, 1 vial product, 1 vial diluent - 0.44 g - 72 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Diluent, Type 1, 20mL, with chlorobutyl rubber stopper - 20 mL - 72 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, multi-dose, Type 1, 50mL, with chlorobutyl rubber stopper - 0.44 g - 72 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)
2017-07-12
Celltrion Healthcare New Zealand Limited CMI Trastuzumab 150 mg, 440mg Powder for Injection for IV Infusion 1 CONSUMER MEDICINE INFORMATION HERZUMA ® TRASTUZUMAB 150 MG AND 440 MG POWDER FOR INJECTION FOR INTRAVENOUS INFUSION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about HERZUMA infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given HERZUMA against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT HERZUMA IS USED FOR HERZUMA contains the active ingredient trastuzumab. HERZUMA belongs to a group of medicines known as antineoplastic (or anti-cancer) agents. There are many different classes of antineoplastic agents. HERZUMA belongs to a class called monoclonal antibodies. Monoclonal antibodies are proteins made in a laboratory. These proteins are designed to recognise and bind to other unique proteins in the body. HERZUMA binds selectively to a protein called human epidermal growth factor receptor 2 (HER2). HER2 is found in large amounts on the surface of some cancer cells. When HERZUMA binds to HER2 it stops the growth and spread of the cancer cells. HERZUMA is used to treat breast and gastric cancer. It is only used in patients whose tumours has tested positive to HER2. HERZUMA may be used alone or with other medicines that treat breast cancer, such as an aromatase inhibitor (hormone receptor positive breast cancer) or a taxane (e.g. paclitaxel or docetaxel). For the treatment of gastric cancer, HERZUMA is used with the chemotherapy medicines cisplatin and capecitabine (or 5FU). For further information about other medicines you are receiving with HERZUMA, please ask your doctor, nurse or pharmacist for the Consumer medicine Information (CMI) leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY Q Lire le document complet
1 NEW ZEALAND DATA SHEET 1. NAME OF MEDICINE HERZUMA ® 150 mg POWDER FOR INJECTION FOR INTRAVENOUS INFUSION HERZUMA ® 440 mg POWDER FOR INJECTION FOR INTRAVENOUS INFUSION Herzuma is a biosimilar medicine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT Trastuzumab. Dosage Preparations: Herzuma 150 mg single-dose vial contains 150 mg trastuzumab and Herzuma 440 mg multi-dose vial contains 440 mg trastuzumab as a powder for injection for intravenous infusion. Reconstituted Herzuma concentrate contains 21 mg/mL of trastuzumab. For the full list of excipients, see section 6.1. The prescribing physician should be involved in any decision regarding interchangeability (unless the product is known to be non-interchangeable). Additional information is available on the following website ( www.medsafe.govt.nz/profs/RIss/Biosimilars.asp ). Data comparing Herzuma to reference product (Herceptin ® ) can be found under “5. Pharmacological properties” section of this datasheet. Trastuzumab is a recombinant DNA derived humanized monoclonal antibody that selectively targets the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). The antibody is an IgG1 kappa that contains human framework regions with the complementarity determining regions of a murine anti-p185 HER2 antibody that binds to HER2. Trastuzumab is composed of 1,328 amino acids and has a molecular weight of ~148 kDa. The humanized antibody against HER2 is produced by recombinant mammalian cells (Chinese hamster ovary (rch)) in suspension culture in a nutrient medium and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. 3. PHARMACEUTICAL FORM Powder for injection for intravenous infusion. Herzuma is a white to pale yellow lyophilized powder. The Herzuma 440 mg solvent is a clear to slightly opalescent liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 2 METASTATIC BREAST CANCER Herzuma is indicated for the treatment of patients with metastatic Lire le document complet